FDA Adverse Event Injury Summary report: N

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

MDR report key: 20985965 · Received December 20, 2024

Report

Report Number: 3005180920-2024-01084
Event Type: Injury
Date Received: December 20, 2024
Date of Event: November 29, 2024
Report Date: December 20, 2024
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
PMA / PMN Number: K112115
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 05-DEC-2024: LOT 130326: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-05-2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT REVISED: BATCH REVIEW PERFORMED ON 05-DEC-2024: LINER: VERSAFITCUP DM 01.26.3644HCT FLAT PE HC LINER Ø36/E (K120531) LOT 134669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-11-2013. EXPIRATION DATE: 2018-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

Description of Event or Problem · 0

AT ABOUT 10 YEARS AND 9 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2203574	MECTACER BIOLOX DELTA FEMORAL BALL HEAD	FEMORAL HEAD Ø 36 SIZE L	LZO	MEDACTA INTERNATIONAL SA	01.29.210	130326

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR	Male	Required Intervention